NCT04285645

Brief Summary

Injuries to the lower limbs are the most common in rugby and within the lower limbs, the most common are those that affect the ligaments of the knee. That is why we will try to improve knee stability and quadriceps strength. The aim of this study is to evaluate the effectiveness of performing a pre-workout exercise protocol to improve knee stability and quadriceps strength in rugby players. Randomized controlled study, simple blind and with follow-up. 30 semi-professional rugby players will be randomized to the two study groups: experimental (pre-training exercise protocol that will include continuous running, squats, and squats and monopodal jumps) and control (without intervention). The intervention will last 4 weeks, with 2 weekly sessions of 15 minutes each. The study variables will be: knee stability (Y-Balance) and quadriceps strength (Single leg hop). The sample distribution will be calculated using the Kolmogorov-Smirnov test. The changes after each evaluation will be analyzed with the t-student test and with an ANOVA of repeated measures, the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula. It is expected to see improvement in knee stability and quadriceps strength in athletes who performed the exercise protocol, after the study period.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2020

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

February 25, 2020

Last Update Submit

September 1, 2021

Conditions

Keywords

RugbyInjuryKneeStabilityStrength Training

Outcome Measures

Primary Outcomes (1)

  • Change from baseline knee stability after treatment and at month

    It will be done using the Y-Balance test. The barefoot sportswoman will be placed with the toes in the center of the Y marked on the floor with adhesive tape. Each of them will have six trials with each foot in each direction (anterior, posterolateral and posteromedial). Subsequently, they will have three attempts with each leg in each direction, taking the best mark of each leg in each direction. The athlete must return to the initial position without losing balance, because if she does not succeed, that attempt will be void. The distance to be measured includes from the central mark where we place the toes to the point where the patient supports the tip of the toes. The unit of measure of this measuring instrument is the centimeter. A higher score indicates greater knee stability.

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Secondary Outcomes (1)

  • Change from baseline quadriceps strength after treatment and at month

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Study Arms (2)

Experimental group

EXPERIMENTAL

Each session will last 15 minutes, taking place 2 days a week, over a period of 4 weeks. Prior to training, the exercise protocol will be carried out. Prior to the start of the intervention, the exercises to be performed will be explained to the participants and it will be verified that they are capable of performing them correctly.

Other: Warmup

Control group

NO INTERVENTION

Athletes included in the control group will continue with their usual training routine.

Interventions

WarmupOTHER

The intervention through exercises will consist in the application of the protocol described by Waldén et al. The objective of the application of this exercise protocol is to produce an improvement in the stability of the knee and the strength of the quadriceps. Before carrying out the exercises, a continuous race will be carried out for 5 minutes, once this first step is finished we will proceed to the realization of the exercises that will be, squats with both legs placing the hands on the hips, feet placed at the width of the shoulders, lowering with a straight back and without raising the heels of the floor, 3 series of 15 repetitions, squats on one leg with the hands on the hips and leg not supported extended forward, 3 sets of 10 repetitions with each leg and jump forward with one leg with the hands on the hips and jump back to return to the starting position, 3 sets of 10 repetitions with each leg

Also known as: Experimental group
Experimental group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female rugby players
  • With an age range of 18 to 30 years
  • That participate in the Valencian territorial category 1
  • Without diagnosis of lower limb injury at the time of starting the study

You may not qualify if:

  • Players who suffer an injury or illness that prevents them from performing the protocol
  • Are performing another specific physiotherapy program of knee stability and quadriceps strength
  • Who had undergone the anterior cruciate ligament less than a year ago
  • Have not signed the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Madrid, Comunity of Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Warm-Up Exercise

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 26, 2020

Study Start

March 1, 2020

Primary Completion

May 20, 2020

Study Completion

June 10, 2020

Last Updated

September 5, 2021

Record last verified: 2021-09

Locations